Informational MDSAP Substantial change / Change of notice forms

#1
Hello,

First of all, I am sorry, as I was not sure if this is the correct thread where I should address this.

We are currently preparing for MDSAP and right now I am working on having the Substantial change and change of notice forms for each country as per the requirements. However, they seem to be called differently in each country and I am a bit lost (eg. TGA: conformity assessment certification = notification of change?).

For substantial change we plan to do was single file (a section for each country) and for notification of change a document for each one.

Could anyone help clarifying the name and corespondent for each? Once this is clear to me I can start working on creating/ updating the template accordingly.

Any piece of information would be very useful. Thank you!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
In Australia "Conformity Assessment" means a verification that the manufacturer and device(s) are in compliance (conformity) with the applicable regulations.
"Conformity Assessment Procedure" means a route, prescribed in the regulations, that is followed for performing the Conformity Assessment (similar to the EU MDD Annexes).
"Conformity Assessment Certification" is the auditing process that normally leads to issuing a certificate attesting that a correct Conformity Assessment Procedure has been completed successfully (similar to an EC certificate).

It is not a notification of change.
 
#3
Thank you very much for clarifying, this is very useful. I could see that they have notification of substantial change (https://www.tga.gov.au/book-page/4-notification-substantial-changes-and-transfers), but what do they use for the notification of change? I am actually struggling in general to understand the process of submitting substantial changes and notification of changes to the regulatory authorities (not just for Australia) because I never really handled it in my area of work (I started in QA working strictly just on post market surveillance, then one year into it switched to taking care of an entire QMS, so the amount of information is sometimes a bit overwhelming).
 
Thread starter Similar threads Forum Replies Date
C Substantial Change in MDSAP Audit Other Medical Device Regulations World-Wide 1
chris1price MDSAP and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
M MDSAP required for Device Initial Importer/Distributor into Canada? Other Medical Device Regulations World-Wide 11
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 6
S Where to start for MDSAP for Canada? Canada Medical Device Regulations 5
Z Steps to take before an MDSAP audit for Canada Canada Medical Device Regulations 3
S Submit to Health Canada with only MDSAP report? Canada Medical Device Regulations 5
B Site removal from MDSAP multi-site Certificate ISO 13485:2016 - Medical Device Quality Management Systems 4
B MDSAP Withdrawal? ISO 13485:2016 - Medical Device Quality Management Systems 1
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
V MDSAP Requirements for Device Designer Canada Medical Device Regulations 1
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
Ed Panek COVID 19 Exception and MDSAP Canada Medical Device Regulations 5
A MDSAP Audit Questionnaire Medical Device and FDA Regulations and Standards News 7
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 11
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
Nikki9154 MDSAP inquiry for China Contract Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 5
K MDSAP Audit Approach 2020 for Brazil Other Medical Device Regulations World-Wide 1
K MDSAP Audit Approach 2020 ISO 13485:2016 - Medical Device Quality Management Systems 4
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
R Exporting to Canada and MDSAP Canada Medical Device Regulations 7
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDSAP and 13485:2016 gap analysis Quality Management System (QMS) Manuals 1
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
M MDR Impact on MDSAP Countries Other Medical Device Regulations World-Wide 16
Watchcat What's up with MDSAP lately? Medical Device and FDA Regulations and Standards News 2
R What happens during a Stage 1 MDSAP audit? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Comparison essential requirements EU compared to those of MDSAP countries Other Medical Device Regulations World-Wide 3
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
J MDSAP Companion and HC requirements Canada Medical Device Regulations 4
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 19
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 6
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
B MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record Other Medical Device Regulations World-Wide 3
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
XRAY_3121 Informational MDSAP Audit Findings - Document change orders Other Medical Device Regulations World-Wide 12
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
M Medical Device News EU interesting developments – embracing MDSAP and UDI alignment Medical Device and FDA Regulations and Standards News 0
M Medical Device News MDSAP Stakeholder Day – December 5, 2018 presentations Medical Device and FDA Regulations and Standards News 0
Ajit Basrur MDSAP Presentations - Dec 5, 2018 - Stakeholders Other Medical Device Regulations World-Wide 0
JoshuaFroud FDA Form MDSAP AU F0029.1.004 - Help with Completion US Food and Drug Administration (FDA) 0
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 13
Sidney Vianna Interesting Discussion Article from Grant Ramaley in QD - MDSAP: When Is a Certificate Not a Certificate? Canada Medical Device Regulations 0
T MDSAP AO Cost ISO 13485:2016 - Medical Device Quality Management Systems 2
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2

Similar threads

Top Bottom